Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \>6 to \<30 mm in Diameter, Determined by LDCT.
Is able to give signed informed consent and comply with study requirements.
≥50 - 80 years of age.
current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years.
Has a >6 to <30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 6 weeks of the prestudy baseline CT scan.
Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).
The dominant nodule is ground glass or part solid as determined by CT scan.
Has 5 or more nodules sized >4 mm.
The nodule sized >6 to <30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.
Single group
Standard medical treatment
Other interventionStandard of care follow up per institution
Standard medical treatment
Other interventionSOC per institution
Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum
Evaluate the clinical performance (positive percent agreement \[PPA/sensitivity\] and negative percent agreement \[NPA/specificity\]) of the FlowPath Lung test in predicting lung cancer from the sputum of high-risk individuals with lung nodules
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